K961716 is an FDA 510(k) clearance for the VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE. This device is classified as a Catheter, Embolectomy (Class II - Special Controls, product code DXE).
Submitted by Ideas For Medicine, Inc. (Clearwater, US). The FDA issued a Cleared decision on September 19, 1996, 140 days after receiving the submission on May 2, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.
| 510(k) Number | K961716 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 1996 |
| Decision Date | September 19, 1996 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXE — Catheter, Embolectomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |